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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036141
Receipt No. R000041171
Scientific Title Effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture for healthy subjects: crossover, placebo controlled randomized clinical trial
Date of disclosure of the study information 2019/04/01
Last modified on 2019/06/12

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Basic information
Public title Effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture for healthy subjects: crossover, placebo controlled randomized clinical trial
Acronym Effects on postprandial blood glucose triglyceride levels of confectionery made using Naked barley grown for healthy subjects: randomized clinical trial
Scientific Title Effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture for healthy subjects: crossover, placebo controlled randomized clinical trial
Scientific Title:Acronym Effects on postprandial blood glucose triglyceride levels of confectionery made using Naked barley grown for healthy subjects: randomized clinical trial
Region
Japan

Condition
Condition Postprandial blood glucose and triglyceride levels
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to examine the effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture compared with confectionery without Naked barley for healthy subjects by crossover, placebo controlled randomized clinical trial
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postprandial blood glucose and triglyceride levels, and their area under the curve
Key secondary outcomes 1.Postprandial blood insulin level, and its area under the curve
2.Subjective appetite change after test meals
3. Gastrointestinal symptoms after test meals

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Firstly, the participants eat the test meal (bread 25g and butter 10g).
After eating test meal, the participants subsequently eat confectionery made using Naked barley (102g) in the intervention group.
Interventions/Control_2 Firstly, the participants eat the test meal (bread 25g and butter 10g).
After eating test meal, the participants subsequently eat placebo confectionery made using wheat (95g) in the control group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria Healthy men and women of 20 to 69 years of age at entry
Key exclusion criteria 1. Body mass index less than 18.5 kg / m 2, or, over 30 kg / m 2
2. Persons undergoing treatment for hypertension, dyslipidemia, diabetes, cancer, ischemic heart disease, cerebrovascular disease, chronic kidney disease, dementia, severe digestive system diseases
3. Women during pregnancy or lactation period
4. Food allergy of food to be provided (wheat, barley, peanuts, eggs)
5. The physician consider the individuals as inappropriate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koutatsu Maruyama
Organization Ehime University
Division name Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department of Bioscience, Graduate School of Agriculture
Zip code
Address 3-5-7 Tarumi, Matsuyama, Ehime
TEL 089-946-9960
Email maruyama.kotatsu.rt@ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koutatsu Maruyama
Organization Ehime University
Division name Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department o
Zip code
Address 3-5-7 Tarumi, Matsuyama, Ehime
TEL 089-946-9960
Homepage URL
Email maruyama.kotatsu.rt@ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 11 Month 30 Day
Date of IRB
2019 Year 03 Month 01 Day
Anticipated trial start date
2019 Year 03 Month 21 Day
Last follow-up date
2019 Year 06 Month 01 Day
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 09 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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